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Genetic Metabolic Diseases AC's First Meeting Will Be Long On Temporary Voting Members

 
• By Sue Sutter and Derrick Gingery

The US FDA’s Genetic Metabolic Diseases Advisory Committee will comprise three regular voting members and 13 temporary members, including some adcomm veterans, when it reviews Zevra Denmark’s arimoclomol for Niemann-Pick disease type C.

Temporary and permanent
With only a few permanent members recruited so far, GeMDAC will have a lot of temporary members at its first meeting. • Source: Shutterstock

The first meeting of the US Food and Drug Administration’s Genetic Metabolic Diseases Advisory Committee will be heavy on temporary voting members, several of whom are veterans of the adcomm process.

More from US FDA Performance Tracker

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 
• By Bridget Silverman

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 
• By Bridget Silverman

The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.

More from Regulatory Trackers

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others

 
• By Eliza Slawther

The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 
• By Bridget Silverman

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.